P100 - Hemp-Based Topical Therapy versus Standard Topical Nifedipine–Lidocaine for Chronic Anal Fissure: A Double-Blind Randomized Controlled Trial

Purpose/Background: Chronic anal fissure (CAF) is a painful and disabling anorectal disorder commonly treated with topical nifedipine-lidocaine ointment. Although effective, adverse effects and limited tolerability often hinder compliance. Hemp-based herbal formulations have shown promise in pilot studies but have not been compared in randomized trials. This study aimed to evaluate the efficacy, safety, and patient-reported outcomes of a hemp-based topical compared with standard nifedipine-lidocaine therapy in the management of CAF.

Methods/Interventions: This prospective, double-blind randomized controlled trial included 50 adults with CAF persisting for at least three weeks. Patients were randomized 1:1 to receive either nifedipine-lidocaine (standard therapy) or the hemp-based ointment containing hemp seed oil, calendula, arnica, almond oil, myrtle, and marine algae extracts (Proctofiz©, ESPA Biomedical Ltd, Ramat Hasharon Israel). Ointments were identical in appearance and applied three times daily for six weeks, with assessments at baseline, weeks 1, 3, 6, 12, and 24. The primary outcome was reduction in pain (VAS); secondary outcomes included bleeding, burning, fissure healing, adverse events, quality of life (QoL), and fissure-specific questionnaire scores (Hemo-Fiss Questionnaire).

Results/Outcomes: Baseline characteristics were comparable. Adverse events were more frequent with standard therapy at week 1 (45.8 % vs 3.8 %, p = 0.001) and week 6 (33.3 % vs 4.3 %, p = 0.031), resolving by week 12. Bleeding declined more rapidly with hemp therapy (week 6 8.7 % vs 44.4 %, p = 0.012; week 12 0 % vs 28.6 %, p = 0.024). Burning was significantly lower at week 3 (20.0 % vs 63.6 %, p = 0.003) and week 6 (13.0 % vs 61.1 %, p = 0.002). Clinical healing favored hemp at week 3 (84.0 % vs 27.3 %, p < 0.001) and week 6 (91.3 % vs 55.6 %, p = 0.012). Pain scores decreased more steeply with hemp therapy (week 3 median 1.0 vs 6.0, p < 0.001; week 6 0.0 vs 2.5, p = 0.001), paralleling QoL gains (week 3 0.0 vs 6.0, p = 0.001).
Analysis of the Hemo-Fiss questionnaire data showed significant within-group improvement only in the Defaecation dimension for standard therapy (p = 0.0105), whereas hemp therapy achieved highly significant improvements across all dimensions: Physical (p < 0.0001), Psychology (p = 0.0004), Defaecation (p < 0.0001), Sexuality (p = 0.0082), and Total (p < 0.0001). Between-group comparisons confirmed superior gains with hemp therapy in Physical (p = 0.0008), Psychology (p = 0.0189), Defaecation (p = 0.0244), and Total (p = 0.0006) scores. Mean improvements were greater with hemp therapy across all dimensions (Physical +1.31 vs +0.25; Psychology +1.00 vs +0.30; Defaecation +2.34 vs +1.20; Sexuality +1.10 vs +0.50; Total +1.41 vs +0.43).

Conclusion/Discussion: The hemp-based topical therapy demonstrated superior efficacy, safety, and patient-reported outcomes compared with standard nifedipine-lidocaine ointment. It provided faster pain relief, higher healing rates, greater improvements in physical and psychological well-being, and fewer adverse events. These findings support hemp-based therapy as a safe, effective, and well-tolerated nonsurgical option for the treatment of chronic anal fissure.

Hemo-Fiss Questionniare Results
Average improvement per dimension by treatment group